MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number H749606916271

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

The reported packaging lot (5230602) for item number h749606916271 had component (b)(4) (lots 5204001 and 5224281) packaged in it.A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The april 2018 angiodynamics complaint report was reviewed for the contrast injection line product family and the failure mode "device leaked." no adverse trend was indicated.As received, the 60" contrast injection line (cil) was returned with what appeared to be dried contrast inside.A visual inspection upon receipt was performed.It was noted during the visual inspection that a piece of the o-ring was broken and was in the fluid path of the cil.An air leak test was then performed which confirmed a leak at the o-ring seal.The customer's compliant description is confirmed.The root cause of leak was caused by a damaged o-ring in the rotating adaptor assembly on the cil.The cil is manually assembled.The o-ring is placed into the cil stem cup using a stylus tool.The rotating adapter (ra) is lubricated, applied onto the stem cup and then swaged onto the cil.The damaged o-ring is a result of the o-ring being placed at an angle inside the cil stem cup.Correct orientation of the o-ring in the stem cup is horizontal, lying flat in the bottom of the stem cup.With the o-ring tilted, it allows the o-ring to be damaged by the rotating adaptor (ra) component as it was assembled onto the stem cup and swaged.When the rotating adaptor (ra) is placed onto the stem cup with a tilted o-ring a portion of the o-ring may be forced into the lumen below the stem cup or the o-ring may be cut.The root cause of the o-ring being placed in the stem cup at an angle was a result of operator error during the manual assembly process.This device non-conformance was not observed during the 100% visual inspection of the ra/o-ring post assemble.Tooling for applying the o-ring into the stem cup, and the swage machine for the swaging process of the ra were reviewed.No issues were discovered.Correction/corrective actions: all employees who worked on the cil lots used in the reported packaging lot were retrained on the applicable procedures.(b)(4).

Event Description

As reported by end user hospital in (b)(6), "leakage was observed from the connection.Although secured and tightened the connection still leaked." o-ring in manifold rotating adaptor was found to be broken.There was no patient injury.The used device has been returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 7641693
• MDR Text Key: 112459478
• Report Number: 1317056-2018-00123
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: H749606916271
• Device Lot Number: 5230602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1